Mirage FX - Medical nasal mask ResMed - Free user manual and instructions

USER MANUAL Mirage FX ResMed

Transparent medical device with a cap and label 'RESMED' attached, no visible text or symbols on the device itself.

ResMed

Mirage™ FX / Mirage™ FX for Her

NASAL MASK

Fitting / Anlegen / Mise en place / Applicazione / Colocación / Colocação / Opzetten / Топоθέτηση της μάσκας / Zakładanie / A maszk felhelyezése / Надевание / Nasadzovanie / Maskenin takılması / Nasazení masky

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ResMed Mirage FX

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Disassembly / Auseinanderbau / Démontage / Smontaggio / Desmontaje / Desmontagem / Demonteren / Апосунармулόγηση / Demontaż / Szétszerelés / Разборка / Rozobratie / Sökme / Demontáž masky

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Reassembly / Zusammenbau / Remontage / Riassemblaggio / Nuevo montaje / Nova montagem / Opnieuw monteren / Επανασυναρμολόγηση / Ponowny montaż / Ismételt összeszerelés / Повторная сборка / Opätovné zostavenie / Yeniden montaj / Opětovné sestavení masky

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Mirage FX / Mirage FX for Her

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Mask components / Maskenkomponenten / Composants du masque / Componenti della maschera / Piezas de la mascarilla / Componentes da máscara / Maskeronderdelen / Εξαρτήματα της μάσκας / Elementy maski / A maszk alkatrészei / Компоненты маски / Komponenty masky / Maske bileşenleri / Součásti masky

	MirageFX	MirageFX for Her
1 Mask frame / Maskenrahmen / Entourage rigide /Telaio della maschera / Armazón de la mascarilla /Armação da máscara / Maskerframe / Πλαίσιομάσκας / Ramka maski / A maszk kerete / Kopnycмаски / Rám masky / Maske çerçevesi / Tělo masky	6211362127 (W)	62143
2 Forehead support / Stirnstütze / Support frontal /Supporto frontale / Apoyo para la frente / Suporteda testa / Voorhoofdsteun / Στήριγμα μετώπου /Wspornik czołowy / Homloktámasz / Лобный упор /Čelná podpora / Alın desteği / Držák čelní příchytky	—	—
3 Cushion / Maskenkissen / Bulle / Cuscinetto /Almohadilla / Almofada / Kussentje / Μαξιλάρι /Uszczelka / Párna / Уплотнитель / Poduška / Yastík /Polštářek	6211162125 (W)	62136
4 Vent / Ausatemöffnung / Orifice de ventilation /Fori per l’esalazione / Orificios de ventilación /Respiradouro / Ventilatiegedeelte /Άνοιγμαεξαερισμού / Otwór odprowadzający powietrze /Kifúvó nyílás / Порт сброса воздуха / Vetrací otvor /Hava deliği / Větrací otvor	—	—
5 Headgear / Kopfband / Harnais / Copricapo /Arnés / Arnês / Hoofdstel / Ιμάντες κεφαλής /Część nagłowna / Fejpánt / Головной фиксатор /Náhlavná súprava / Başlík / Náhlavní souprava	6211062138 (S)	62129
6 Elbow assembly / Kniestück-Baugruppe /Ensemble coude / Gruppo del gomito / Conjuntodel codo / Conjunto do cotovelo / Completebocht / Συγκρότημα γωνιακού εξαρτήματος / Zespółkolanka / Könyökidom-szerelvény / Угловойпатрубок в сборе / Sústava kolena / Dirsek takımı /Rameno masky	—	—
7 Elbow side tabs / Seitliche Knöpfe des Kniestücks / Pattes d'attache latérales coude / Alette laterali del gomito / Lengüetas laterales del codo / Patilhas laterais do cotovelo / Vergrendelknoppen bocht / Плευρικές προεξοχές γωνιακού εξαρτήματος / Boczne zapadki kolanka / A könyök oldalsó fülei / Боковые зажимы углового патрубка / Bočné kolíky kolena / Dirsek yan çıkintiları / Postranní příchytky	—	—
A Complete system / Komplettes System / Masque complet / Sistema completo / Sistema completo / Sistema completo / Volledig systeem / Πλήρες σύστημα / Cały system / Teljes rendszer / Полная система / Kompletný systém / Komple sistem / Kompletní systém	6210262117 (W)	62139
B Elbow Assembly / Kniestück-Baugruppe / Ensemble coude / Gruppo del gomito / Conjunto del codo / Conjunto do cotovelo / Complete bocht / Συγκρότημα γωνιακού εξαρτήματος / Zespół kolanka / Könyökidom-szerelvény / Угловой патрубок в сборе / Sústava kolena / Dirsek Takımı / Rameno masky	62114 62114

S Small / Small / Petit / Small / Pequeña / Pequena / Small / Микро / Mała / Kicsi / Malенькая / Malá / Küçük / malá W Wide / Wide / Large / Wide / Ancha / Grande / Wide / Платú / Szeroka / Széles / Широкая / Široká / Geniş / široká

Mirage™ FX / Mirage™ FX for Her

NASAL MASK

Thank you for choosing the Mirage FX / Mirage FX for Her. Please read the entire manual before use.

Intended use

The Mirage FX / Mirage FX for Her channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device.

The Mirage FX / Mirage FX for Her is:

- to be used by patients (> 30 kg) for whom positive airway pressure has been prescribed

- intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

Clinical benefits

The clinical benefit of vented masks is the provision of effective therapy delivery from a therapy device to the patient.

Intended patient population/medical conditions

Obstructive pulmonary diseases (eg, Chronic Obstructive Pulmonary Disease), restrictive pulmonary diseases (eg, diseases of the lung parenchyma, diseases of the chest wall, neuromuscular diseases), central respiratory regulation diseases, obstructive sleep apnoea (OSA) and obesity hypoventilation syndrome (OHS).

WARNING

- The mask contains safety features, eg, exhaust vent and valve, to enable normal breathing and exhaust exhaled breath. Occlusion of the exhaust vent or valve needs to be prevented to avoid having an adverse effect on the safety and quality of the therapy. Regularly inspect the vent and valve to ensure it is kept clean, clear of blockages and is not damaged.

- This mask should only be used with CPAP or bilevel devices recommended by a physician or respiratory therapist.

- The mask should not be used unless the device is turned on. Once the mask is fitted, ensure the device is blowing air.

Explanation: CPAP and bilevel devices are intended to be used with special masks (or connectors) which have vent holes to allow continuous flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask vent holes. However, when the device is not operating, insufficient fresh air will be provided through the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. This applies to most models of CPAP or bilevel devices.

• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the CPAP or bilevel device is not operating, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire.
• Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. Only use oxygen in well ventilated rooms.
• Remove all packaging before using the mask.

Note: For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country.

Using your mask

When using your mask with ResMed CPAP or bilevel devices that have mask setting options, refer to the Technical specifications section in this user guide for mask setting options.

For a full list of compatible devices for this mask, see the Mask/Device Compatibility List on www.resmed.com/downloads/masks. If you do not have internet access, please contact your ResMed representative.

Note:

If you experience nasal dryness or irritation, using a humidifier is recommended.

Fitting

The fitting illustrations section in this user guide show the sequence for obtaining the best fit and comfort when using your mask.

Fitting steps

Prior to fitting your mask, remove the elbow from the mask by pressing the side tabs. Connect the elbow to your device air tubing.

1. With both lower headgear straps released, hold the mask against your face and pull the headgear over your head.
2. Bringing the lower straps below your ears, loop the headgear into the lower hooks on the mask frame.
3. Unfasten the Velcro ^® , pull the upper headgear straps evenly until they are comfortable and reattach the Velcro. Do not overtighten.
4. Repeat step 3 with the lower headgear straps.
5. Attach the combined elbow assembly and air tubing to the mask by pressing the side-tabs and pushing into mask frame.
6. Your mask and headgear should be positioned as shown. Ensure the headgear label is facing outwards.

Removing the mask

Refer to the removal illustrations section in this user guide. To remove your mask, disconnect one of the lower headgear hooks and pull the mask and headgear up over your head.

Disassembly

Refer to the disassembly illustrations in this user guide.

Disassembly steps

1. Unhook the upper headgear straps from the mask frame, there is no need to undo the Velcro.
2. Remove the combined elbow assembly and air tubing from the mask by pressing the side-tabs and pulling away from the mask frame. Remove the elbow assembly from the air tubing.
3. Gently separate the cushion from the mask frame.

Reassembly

Refer to the reassembly illustrations in this user guide.

Reassembly steps

1. Ensure the cushion is oriented correctly by aligning the top cushion tab with the recess in the top of the mask.
2. Gently pull the cushion through the front of the mask frame until the cushion locks securely into the mask frame. The tabs on either side of the cushion should be sitting against the mask frame. Ensure the cushion is not twisted or distorted.
3. Attach the top headgear straps to the mask frame by looping onto each of the upper headgear hooks.
4. Replace the elbow assembly into the air tubing and attach the combined elbow assembly and air tubing to the mask by pressing the side-tabs and pushing into the mask.

Cleaning your mask in the home

Your mask and headgear should only be gently handwashed.

Daily/After each use:

• Disassemble the mask components according to the disassembly instructions.
• Thoroughly clean the separated mask components (excluding headgear), by gently rubbing in warm (approximately 86^ / 30^ ) water using mild soap.
• To optimise the mask seal, facial oils should be removed from the cushion after use.
• Use a soft bristle brush to clean the vent.
• Inspect each component and if required, repeat washing until visually clean.
• Rinse all components well with drinking quality water and allow to air dry out of direct sunlight.
• When all components are dry, reassemble according to the reassembly instructions.

Weekly:

- Handwash the headgear.

WARNING

Do not use aromatic-based solutions or scented oils (eg, eucalyptus or essential oils), bleach, alcohol or products that smell strongly (eg, citrus) to clean any of the mask components. Residual vapours from these solutions can be inhaled if not rinsed thoroughly. They may also damage the mask.

CAUTION

If any visible deterioration of a system component is apparent (cracking, crazing, tears etc), or, if after cleaning, any component remains unclean, the component should be discarded and replaced.

Reprocessing the mask between patients

This mask should be reprocessed when used between patients. Cleaning, disinfection and sterilisation instructions are available from the ResMed website, www.resmed.com/downloads/masks. If you do not have internet access, please contact your ResMed representative.

Troubleshooting

Problem/possible cause Solution

Mask is too noisy

Vent is blocked or partially blocked. If the vent requires cleaning, use a soft bristle brush.

Elbow incorrectly inserted. Remove the elbow from the mask and then reassemble according to the instructions.

Mask leaks around the face

Mask not positioned correctly. Gently pull the cushion away from the face to reinflate. Reposition your mask according to the instructions.

Air leaking around the bridge of the nose.

Mask is not tightened correctly. Tighten top headgear straps. Do not overtighten.

Air leaking around the sides of the nose

Mask is not tightened correctly.

Tighten both upper and lower headgear straps. Do not overtighten.

Turn off the CPAP or bilevel device and remove mask. Refit the mask according to the instructions.

Ensure you position the cushion correctly on the face before pulling headgear over the head.

Do not slide mask down the face during fitting as this may lead to folding or curling of the cushion.

The mask does not fit properly

Mask is incorrectly assembled.

Disassemble the mask, then reassemble according to the instructions.

Cushion may be dirty. Clean

cushion according to the instructions.

Mask may be the wrong size

Talk to your clinician to have your face size checked against the fitting template. Note that sizing across different masks is not always the same.

WARNING

• The technical specifications of the mask are provided for your clinician to check that they are compatible with the CPAP or bilevel device. If used outside specification or if used with incompatible devices; the seal and comfort of the mask may not be effective; optimum therapy may not be achieved; and leak, or variation in the rate of leak may affect the CPAP or bilevel device function.
• Discontinue using this mask if you have ANY adverse reaction to the use of the mask, and consult your physician or sleep therapist.

- Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.

- As with all masks, some rebreathing may occur at low CPAP pressures.

- Refer to your CPAP or bilevel device manual for details on settings and operational information.

- At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration varies, depending on the pressure settings, patient breathing pattern, mask, point of application and leak rate. This warning applies to most types of CPAP devices.

Technical specifications

Pressure-flow curve

The mask contains passive venting to protect against rebreathing. As a result of manufacturing variations, the vent flow rate may vary.

Note: The manufacturer reserves the right to change these specifications without notice.

Dead space information	Physical dead space is the empty volume of the mask to the end of the swivel.Mirage FX: 93 mL (FX), 83mL (FX Wide)Mirage FX for Her: 71 mL
Therapy pressure	4 to 20 cm H_2O
Resistance Drop in pressure measured (nominal)at 50 L/min: 0.2 cm H_2O at 100 L/min: 1.0 cm H_2O
Environmental conditions	Operating temperature: +5°C to +40°COperating humidity: 15% to 95% non-condensing.Storage and transport: -20°C to +60°CStorage and transport humidity: up to 95% non-condensing.
Sound DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted sound power level of the mask is 26 dBA, with uncertainty 3 dBA. The A-weighted sound pressure level of the mask at a distance of 1m is 18 dBA, with uncertainty 3 dBA.
Gross dimensions	Mask fully assembled with elbow assembly – no headgear.Mirage FX: 138 mm (H) x 86 mm (W) x 88 mm (D)Mirage FX for Her: 124 mm (H) x 82 mm (W) x 88 mm (D)
Mask setting options	For S9: Select ‘NASAL’For other devices: Select ‘STANDARD’, otherwise select ‘VISTA’ as the mask option.
Service life The service life of the mask system is dependent on the intensity of usage, maintenance, and environmental conditions to which the mask is used or stored. As this mask system and its components are modular in nature, it is recommended that the user maintain and inspect it on a regular basis, and replace the mask system or any components if deemed necessary or according to the ‘Caution’ in the ‘Cleaning your mask in the home’ section of this guide. Refer to the ‘Mask components’ section of this guide for information of how to order replacement parts.

Storage

Ensure that the mask is thoroughly clean and dry before storing it for any length of time. Store the mask in a dry place out of direct sunlight.

Disposal

This mask and packaging does not contain any hazardous substances and may be disposed of with your normal household refuse.

Symbols

The following symbols may appear on your product or packaging.

Caution, consult accompanying documents; Latex made with natural rubber latex; Importer; Medical device.

See symbols glossary at ResMed.com/symbols.

Consumer Warranty

ResMed acknowledges all consumer rights granted under the EU Directive 1999/44/EG and the respective national laws within the EU for products sold within the European Union.

Mirage™ FX/Mirage™ FX for Her

NASENMASKE

Courbe pression/débit

Mirage™ FX/Mirage™ FX for Her

MÁSCARA NASAL

Mirage™ FX/Mirage™ FX for Her

NOSOVÁ MASKA

ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide.

For patent and other intellectual property information, see ResMed.com/ip.

Mirage is a trademark and/or registered trademark of the ResMed family of companies. Velcro is a trademark of Velcro Industries B.V.

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